PMID- 34164938
OWN - NLM
STAT- MEDLINE
DCOM- 20220217
LR  - 20220217
IS  - 2326-5205 (Electronic)
IS  - 2326-5191 (Linking)
VI  - 74
IP  - 1
DP  - 2022 Jan
TI  - A Worldwide Pharmacoepidemiologic Update on Drug-Induced Antineutrophil 
      Cytoplasmic Antibody-Associated Vasculitis in the Era of Targeted Therapies.
PG  - 134-139
LID - 10.1002/art.41902 [doi]
AB  - OBJECTIVE: The literature supporting the role of a specific drug in the onset of 
      drug-induced antineutrophil cytoplasmic antibody-associated vasculitis (AAV) 
      mainly relies on case reports or short series and implicates old treatments. The 
      advent of new treatments may have modified the epidemiology of these adverse drug 
      reactions. This study was undertaken to update the list of drugs associated with 
      AAV by using a pharmacovigilance-based data mining approach. METHODS: We 
      collected data on adverse drug reactions reported using the Medical Dictionary 
      for Regulatory Activities preferred term "anti-neutrophil cytoplasmic antibody 
      positive vasculitis" up to November 2020 from the World Health Organization 
      pharmacovigilance database (VigiBase). For each retrieved drug, a case-noncase 
      analysis was performed, and disproportionate reporting was calculated by using 
      the information component (IC). A positive IC(025) value, which is the lower end 
      of the 95% credibility interval, was considered significant. RESULTS: A total of 
      483 deduplicated individual case safety reports of drug-induced AAV involving 15 
      drugs with an IC(025) >0 were retrieved. Of the individuals with drug-induced AAV 
      for whom data on sex were available (n = 371), 264 (71.2%) were women. The median 
      age at onset of drug-induced AAV was 62 years (quartile 1 [Q1]-Q3 45-72 years), 
      and the median time from the introduction of the suspected drug to the onset of 
      drug-induced AAV was 9 months (Q1-Q3 1-36 months). Drug-induced AAV was 
      considered serious in 472 (98.1%), and was fatal in 43 (8.9%), of 481 cases. The 
      drugs associated with the highest disproportionate reporting were hydralazine, 
      propylthiouracil, thiamazole, sofosbuvir, minocycline, carbimazole, mirabegron, 
      and nintedanib. CONCLUSION: Our findings strengthen the evidence of an 
      association of AAV with previously suspected drugs, but also identify 3 new drugs 
      that may cause drug-induced AAV. Particular attention should be given to these 
      drugs by prescribers and in experimental studies.
CI  - (c) 2021, American College of Rheumatology.
FAU - Deshayes, Samuel
AU  - Deshayes S
AUID- ORCID: 0000-0001-8887-3233
AD  - Normandie Universite, Universite Caen-Normandie, EA4650 SEILIRM, Centre 
      Hospitalier Universitaire de Caen Normandie, Caen, France.
FAU - Dolladille, Charles
AU  - Dolladille C
AD  - Normandie Universite, Universite Caen-Normandie, EA4650 SEILIRM, Centre 
      Hospitalier Universitaire de Caen Normandie, Caen, France.
FAU - Dumont, Anael
AU  - Dumont A
AUID- ORCID: 0000-0003-1105-7662
AD  - Normandie Universite, Universite Caen-Normandie, Centre Hospitalier Universitaire 
      de Caen Normandie, Caen, France.
FAU - Martin Silva, Nicolas
AU  - Martin Silva N
AD  - Normandie Universite, Universite Caen-Normandie, Centre Hospitalier Universitaire 
      de Caen Normandie, Caen, France.
FAU - Chretien, Basile
AU  - Chretien B
AD  - Centre Hospitalier Universitaire de Caen Normandie, Caen, France.
FAU - De Boysson, Hubert
AU  - De Boysson H
AD  - Normandie Universite, Universite Caen-Normandie, EA4650 SEILIRM, Centre 
      Hospitalier Universitaire de Caen Normandie, Caen, France.
FAU - Alexandre, Joachim
AU  - Alexandre J
AD  - Normandie Universite, Universite Caen-Normandie, EA4650 SEILIRM, Centre 
      Hospitalier Universitaire de Caen Normandie, Caen, France.
FAU - Aouba, Achille
AU  - Aouba A
AD  - Normandie Universite, Universite Caen-Normandie, EA4650 SEILIRM, Centre 
      Hospitalier Universitaire de Caen Normandie, Caen, France.
LA  - eng
PT  - Journal Article
DEP - 20211111
PL  - United States
TA  - Arthritis Rheumatol
JT  - Arthritis & rheumatology (Hoboken, N.J.)
JID - 101623795
SB  - IM
MH  - Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*chemically induced
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pharmacoepidemiology
MH  - Retrospective Studies
EDAT- 2021/06/25 06:00
MHDA- 2022/02/19 06:00
CRDT- 2021/06/24 07:03
PHST- 2021/01/28 00:00 [received]
PHST- 2021/06/10 00:00 [accepted]
PHST- 2021/06/25 06:00 [pubmed]
PHST- 2022/02/19 06:00 [medline]
PHST- 2021/06/24 07:03 [entrez]
AID - 10.1002/art.41902 [doi]
PST - ppublish
SO  - Arthritis Rheumatol. 2022 Jan;74(1):134-139. doi: 10.1002/art.41902. Epub 2021 
      Nov 11.